MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE; ANKLE COMPONENTS

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

It was reported that the patient was having instability of the right ankle, associated with pain, noted at 1 year post-op visit.Along with revision of polyethylene component, right lateral ligament reconstruction with internal brace was performed.

Manufacturer Narrative

Section h10: (h3)based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the revision due to instability associated with pain is most likely is related to an underlying condition of the patient.No information provided in the following section(s): b6, d4, d11, g5, g8, h4.

• Brand Name: VANTAGE
• Type of Device: ANKLE COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9070867
• MDR Text Key: 162265241
• Report Number: 1038671-2019-00459
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 83